Medical tools for corneal tissue delivery

Abstract

Devices, kits and tools that facilitate pre-loading, storage, transportation and small incision, partial thickness corneal replacement procedures, including deep lamellar endothelial keratoplasty (DLEK), Descemet's stripping endothelial keratoplasty (DSEK) and Descemet's stripping automated endothelial keratoplasty (DSAEK), using donor eye tissue are provided.

What is claimed is: 
     
       1. A donor corneal tissue storage and delivery device, comprising:
 a storage fluid; 
 a housing having a proximal end and a distal end; 
 a cannula having a proximal end and a distal end, said cannula disposed at a distal end of the housing; 
 a fluid channel connector disposed at a proximal end of the housing; 
 at least one fluid channel with a proximal end and a distal end, the proximal end coupled to the fluid channel connector and the distal end disposed within the proximal end of the cannula; 
 a flexible support configured to receive a donor corneal tissue and retract into the cannula; 
 a retractor shaft coupled to the flexible support; 
 one or more loading members held by the housing, coupled to the retractor shaft and operable to retract the retractor shaft and coupled flexible support thereby retracting the flexible support and donor corneal tissue into the cannula; 
 a deployment shaft coupled to the cannula and configured to retract into the distal end of the housing; 
 one or more deployment members coupled to the deployment shaft and operable to cause the deployment shaft to retract the cannula and to deliver the donor corneal tissue to an implantation site from the flexible support retracted into the cannula; 
 a removable reservoir comprising a reservoir base configured to removably couple the removable reservoir to a distal end of the deployment shaft, wherein the removable reservoir is in fluid communication with the at least one fluid channel and encloses the flexible support and cannula when the removable reservoir is removably coupled to the distal end of the deployment shaft, wherein the removable reservoir is configured to receive the storage fluid for hydrating the donor corneal tissue received by the flexible support while the flexible support is retracted into the cannula; and 
 wherein the at least one fluid channel, cannula, and the removable reservoir are all filled with the storage fluid. 
 
     
     
       2. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the cannula tapers toward the distal end of the housing. 
     
     
       3. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the cannula is slidably retractable relative to the housing, and wherein the device further comprises a locking guard member in communication with the one or more deployment members and configured to inhibit axial retraction of the cannula. 
     
     
       4. The donor corneal tissue storage and delivery device according to  claim 3 , wherein the locking guard member is removable from the housing to allow the one or more deployment members to engage the deployment shaft and to retract the cannula into the housing, wherein the at least one fluid channel remains stationary within the retracting cannula and acts to push the donor corneal tissue out of the cannula. 
     
     
       5. The donor corneal tissue storage and delivery device according to  claim 3 , wherein the one or more deployment members comprise one or more deployment wheels. 
     
     
       6. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the at least one fluid channel is configured to receive irrigation fluid and direct the irrigation fluid to the cannula to provide irrigation to the donor corneal tissue and the implantation site. 
     
     
       7. The donor corneal tissue storage and delivery device according to  claim 6 , further comprising a fluid pressure source configured to releasably engage the fluid channel connector to help deliver the donor corneal tissue into a small incision scleral access site. 
     
     
       8. The donor corneal tissue storage and delivery device according to  claim 7 , wherein the fluid pressure source is selected from the group consisting of syringe, hanging fluid bag, and infusion pump. 
     
     
       9. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the at least one fluid channel is configured to receive irrigation fluid and direct the irrigation fluid to the cannula to provide irrigation to the donor corneal tissue and the implantation site and configured to help flowably deliver the donor corneal tissue when the one or more deployment members is operated. 
     
     
       10. The donor corneal tissue storage and delivery device according to  claim 1 , the cannula is sized to enter an incision less than about 4 mm in length. 
     
     
       11. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the removable reservoir contains the storage fluid, wherein the storage fluid comprises a biocompatible fluid. 
     
     
       12. The donor corneal tissue storage and delivery device according to  claim 11 , wherein the biocompatible fluid is a cornea storage solution. 
     
     
       13. The donor corneal tissue storage and delivery device according to  claim 1 , wherein at least a portion of the cannula is visually transmissive. 
     
     
       14. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the removable reservoir further comprises a reservoir body extending distally from the reservoir base and a reservoir cap distal the reservoir base, the reservoir cap removably coupled to the reservoir body. 
     
     
       15. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the reservoir base is removably coupled to the distal end of the deployment shaft. 
     
     
       16. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the flexible support and donor corneal tissue adopt a rolled shape when retracted into the cannula. 
     
     
       17. The donor corneal tissue storage and delivery device according to  claim 1 , wherein the removable reservoir further comprises a fluid flow restrictor disposed therein. 
     
     
       18. The donor corneal tissue storage and delivery device according to  claim 1 , wherein a proximal portion of the deployment shaft and the retractor shaft are slidably engaged at a junction, the junction including a one-way valve or gasket that inhibits leakage of the storage fluid. 
     
     
       19. A donor corneal tissue storage and delivery device kit, comprising:
 a sterile package; and 
 a donor corneal tissue storage and delivery device in the sterile package, 
 wherein the donor corneal tissue storage and delivery device comprises: 
 a storage fluid; 
 a housing having a proximal end and a distal end; 
 a cannula having a proximal end and a distal end, said cannula disposed at a distal end of the housing; 
 a fluid channel connector disposed at a proximal end of the housing; 
 at least one fluid channel with a proximal end and a distal end, the proximal end coupled to the fluid channel connector and the distal end disposed within the proximal end of the cannula; 
 a flexible support configured to receive a donor corneal tissue and retract into the cannula; 
 a retractor shaft coupled to the flexible support; 
 one or more loading members held by the housing, coupled to the retractor shaft and operable to retract the retractor shaft and coupled flexible support thereby retracting the flexible support and donor corneal tissue into the cannula; 
 a deployment shaft coupled to the cannula and configured to retract into the distal end of the housing; 
 one or more deployment members coupled to the deployment shaft and operable to cause the deployment shaft to retract the cannula and to deliver the donor corneal tissue to an implantation site from the flexible support retracted into the cannula; 
 a removable reservoir comprising a reservoir base configured to removably couple the removable reservoir to a distal end of the deployment shaft, wherein the removable reservoir is in fluid communication with the at least one fluid channel and encloses the flexible support and cannula when the removable reservoir is removably coupled to the distal end of the deployment shaft, wherein the removable reservoir is configured to receive the storage fluid for hydrating the donor corneal tissue received by the flexible support while the flexible support is retracted into the cannula; and 
 wherein the at least one fluid channel, cannula, and the removable reservoir are all filled with the storage fluid. 
 
     
     
       20. The donor corneal tissue storage and delivery device kit of  claim 19 , wherein the removable reservoir contains the storage fluid, wherein the storage fluid comprises a cornea storage solution. 
     
     
       21. The donor corneal tissue storage and delivery device kit of  claim 19 , wherein the removable reservoir further comprises a reservoir body extending distally from the reservoir base and a reservoir cap distal the reservoir base, the reservoir cap removably coupled to the reservoir body. 
     
     
       22. The donor corneal tissue storage and delivery device kit of  claim 19 , wherein the removable reservoir further comprises a fluid flow restrictor disposed therein. 
     
     
       23. The donor corneal tissue storage and delivery device kit of  claim 19 , wherein a proximal portion of the deployment shaft and the retractor shaft are slidably engaged at a junction, the junction including a one-way valve or gasket that inhibits leakage of the storage fluid.